Does Pregabalin Improve Symptoms of Anxiety in Patients With Epilepsy? A Comparison With Sertraline

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01309074
Recruitment Status : Terminated (Only two subjects were enrolled and completed the trial and enrollment of additional subjects was too slow. Accordingly, it was decided to terminate the study.)
First Posted : March 4, 2011
Last Update Posted : December 7, 2012
Information provided by (Responsible Party):
Andres M. Kanner, MD, Rush University Medical Center

Brief Summary:
The aim of the study is to compare the safety & efficacy of sertraline (up to a dose of 200mg/day) & pregabalin (up to a dose of 300mg/day)for the treatment of symptoms of anxiety in patients with epilepsy.

Condition or disease Intervention/treatment Phase
Epilepsy Anxiety Drug: Pregabalin-Lyrica Drug: Sertraline Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Does Pregabalin Improve Symptoms of Anxiety in Patients With Epilepsy? A Comparison With Sertraline
Study Start Date : November 2009
Estimated Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety Epilepsy

Arm Intervention/treatment
Experimental: Pregabalin
Pregabalin is an antiepileptic medication which has been found in double blind placebo controlled trials to be effective and safe in the treatment of primary generalized anxiety disorder. It has an indication for the treatment of this condition in Europe & Canada but not in the US.
Drug: Pregabalin-Lyrica
Pregabalin in a dose up to 300mg/day in BID dosing.
Other Name: Lyrica.

Active Comparator: Sertraline
Sertraline is an SSRI found to be an effective treatment of generalized anxiety disorder in controlled trials. It does not have an indication for this in this country.
Drug: Sertraline
Sertraline in a dose up to 200mg/day in BID dosing.
Other Name: Zoloft.

Primary Outcome Measures :
  1. Improvement of anxiety symptoms measured with the changes of the total scores of GAD-7 & HAM-A. [ Time Frame: 27 weeks ]
    Change in severity of symptoms &/o remission of symptooms of anxiety between visit 0 & the end of treatment phase.

Secondary Outcome Measures :
  1. Change in Quality of life measures assessed with the QOLIE-89. [ Time Frame: 27 weeeks. ]
    A change in the toatal scores of the QOLIE-89 scores as well as in the individual subscales and change in the tolerance of antiepileptic medication assessed with change in the total score of the adverse event profile between baseline & the end of treatment phase.

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • GAD-7 total score above 10.
  • Have a diagnosis of a Partial Seizure Disorder.
  • Have a Hamilton-A total score 20 and above.
  • 18-80 years of age.
  • Able to read at a fourth grade level.
  • If a woman of childbearing age, agrees to use an acceptable means of birth control.

Exclusion Criteria:

  • Unable to understand and sign a consent.
  • Unable to follow instructions for the study.
  • Displaying current suicidal ideation
  • Having psychogenic non-epileptic seizures
  • Have a history of drug or alcohol abuse.
  • Use of any investigational drug within the last 30 days.
  • Hypersensitivity reaction or other serious adverse event to PGB in prior trials.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01309074

United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
Rush University Medical Center
Principal Investigator: Andre M. Kanner, MD Director Laboratory Encephalography, Associate Director Section of Epilepsy and Rush Epilepsy Center and Senior Attending Neurologist Rush University Medical Center.

Responsible Party: Andres M. Kanner, MD, M.D., Rush University Medical Center Identifier: NCT01309074     History of Changes
Other Study ID Numbers: GA0082BY
First Posted: March 4, 2011    Key Record Dates
Last Update Posted: December 7, 2012
Last Verified: December 2012

Keywords provided by Andres M. Kanner, MD, Rush University Medical Center:

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Antidepressive Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Serotonin Agents